Name: Predicase
Price: 199 USD

K-number	K972919
Device name	BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW
Applicant	Bionx Implants, Inc.
Product code	HWC
Device class	Class II
Decision date	Mar 27, 1998
Decision	Substantially Equivalent
Regulation	888.3040

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View the full FDA submission: accessdata.fda.gov

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BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW

Everything you need for a 510(k) submission. Nothing you don't.